South Africa to Become Africa’s First mRNA Vaccine Manufacturing Hub – WHO Asks Big Pharma to Support Scaleup Health Equity 21/06/2021 • Kerry Cullinan Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Afrigen is the lead partner in the South African mRNA hub Africa could start producing its own cutting-edge COVID-19 vaccines within a year via an mRNA technology transfer hub that is being set up in South Africa, the World Health Organization (WHO) announced on Monday. But the speed at which the new hub may be able to swing into full-scale vaccine production depends on whether pharmaceutical companies with proven mRNA vaccines will commit to supporting the initiative, according to WHO Chief Scientist Soumya Swaminathan. WHO is in discussions with “the larger companies that have proven mRNA technology”, and is “hoping very much that they will come on board”, Swaminathan revealed. If a big pharma partner does indeed come forward, vaccines could be produced in South Africa ”within nine to 12 months”, she declared at a WHO media briefing Monday. South African President Cyril Ramaphosa described the hub as a “landmark initiative” that “will put Africa on a path to self-determination” in terms of vaccine development and manufacturing capacity. “We just cannot continue to rely on vaccines that are made outside of Africa because they never come. They never arrive on time. And people continue to die,” Ramaphosa told the WHO briefing. The hub consists of South African companies Afrigen Biologics and Vaccines and Biovac, a network of universities, and the Africa Centre for Disease Control. Afrigen will manufacture the mRNA vaccines and provide training to Biovac, according to WHO Director General Dr Tedros Adhanom Ghebreyesus. “In time, Afrigen could provide training to other manufacturers in Africa and beyond,” said Tedros. Timelines Depend on Big Pharma Support WHO Chief Scientist Soumya Swaminathan If the major mRNA manufacturers – primarily Pfizer and Moderna – do not support the South African hub, the WHO was considering “several options” from smaller biotech companies” that are further back in the development pathway – but this would mean running clinical trials. “The timelines of when vaccines can be produced in the country will depend on whether there’s a tried and tested technology that can be much more easily transferred to the facility in South Africa, which by the way already exists,” said Swaminathan. “There’s already a pilot plant there, so all we would need is to put in some equipment and train the workforce on this new process, and … [source] all the raw materials and things that are going to be needed for this.” Running trials would delay manufacture, but “the good thing is South Africa has huge capacity in clinical trials in R&D and the regulatory agency there is very strong and up to speed,” she added. French Welcome Hub to ‘Respond to Variants’ The hub has the support of the French government, and President Emmanuel Macron said in a recorded message that it would “allow for a rapid response to develop new vaccines to address new variants of COVID-19 or newly emerging pathogens on the African continent, and for the benefit of the entire world”. The announcement follows the recent visit to South Africa by Macron, who said his country was committed to supporting African efforts to scale up their local manufacturing capacity of COVID-19 vaccines and other medical solutions. However, Ramaphosa stressed at the briefing that the hub needed to go hand in hand with the TRIPS waiver that his country and India are pushing for at the World Trade Organization, to ensure that “real intellectual property can be transferred”. The hub stems from a call made by the WHO in April for Expressions of Interest (EOI) to establish COVID mRNA vaccine technology transfer hubs to scale up production and access to COVID vaccines. “Technology transfer hubs are training facilities where the technology is established at industrial scale and clinical development performed,” according to the WHO. “Interested manufacturers from low- and middle-income countries can receive training and any necessary licenses to the technology. WHO and partners will bring in the production know-how, quality control and necessary licenses to a single entity to facilitate a broad and rapid technology transfer to multiple recipients.” WTO is Addressing Vaccine Production Bottlenecks, Local Production Forum Hears World Trade Organization Director-General Ngozi Okonjo-Iweala Earlier in the day, governments, agencies and the private sector met virtually for the start of the World Local Production Forum, a global arena to discuss “opportunities and mechanisms for the promotion of local production and technology transfer”. Addressing the opening of the forum, WTO Director-General Ngozi Okonjo-Iweala said that “before the pandemic, 10 countries accounted for 80% of global vaccine exports”. “We have now seen that over-centralization of vaccine production capacity is incompatible with equitable access in a crisis situation,” said Okonjo-Iweala. “At the same time, the complexity of global supply chains necessary to manufacture COVID-19 vaccines makes clear that it is difficult for any one nation to produce everything in the entire value chain,” she added. She and other speakers promoted the idea of regional production hubs, pointing out that Africa is already working with the European Union and other partners to advance such a hub involving South Africa, Senegal and Rwanda. “Regional hubs can combine economies of scale with increased geographical diversification as called for by the World Health Assembly Resolution on strengthening local production,” she added. “In the current crisis, the WTO can help by freeing up supply chains, by removing export restrictions and facilitating cross border trade.” The WTO is hosting a supply chain transparency symposium later this month to identify blockages in supply. Next month it will co-host a meeting with WHO and vaccine manufacturers “to explore potential partnerships and investment opportunities particularly in emerging markets and developing countries”. Meanwhile, UNICEF executive director Henrietta Fore told the forum: “When products are manufactured closer to the people who need them, supply chains are more efficient, shipping costs are lower, shipping times are faster, and our operations have a much smaller environmental impact.” South Africa’s Director-General of Health, Sandile Buthelezi, said that Africa is reliant on India and China for generic medicine and active pharmaceutical ingredients. “Importation of medical commodities from these countries, while critical for meeting the healthcare needs of many low-income countries, has an impact on the trade balance of African countries,” said Buthelezi. He identified training of personnel – particularly chemical engineers, pharmaceutical scientists and technicians – and a supportive regulatory environment that included the “removal of obstacles related to intellectual property” as being priorities to enable local production. Image Credits: Afrigen. 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